D-0029-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 1, 2017
- Initiation Date
- September 15, 2017
- Termination Date
- June 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 628,000 applicators
Product Description
ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
Reason for Recall
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
Distribution Pattern
IL, MO, PA, TN, & VA
Code Information
Lot 7096622, exp 3/21/2020